FDA approval smooths way to more Botox sales

While Botox still primarily springs to mind as a cosmetic treatment for wrinkles, the Allergan ($AGN) drug has been approved for 26 indications in 85 countries. The latest, and one it has been longing for, is an FDA approval of Botox as a treatment for adults with leaky bladders who don't respond to other drugs.

The agency Friday OK'd Botox to treat adults with an overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics. The FDA said that when Botox is injected into the bladder muscle, it causes the bladder to relax. "Clinical studies have demonstrated Botox's ability to significantly reduce the frequency of urinary incontinence," said Hylton V. Joffe, M.D., director of the Division of Reproductive and Urologic Products.

Allergan, which has yet to file its 2012 results, had projected Botox sales of $1.76 billion to $1.8 billion last year. Analysts have said that approval for overactive bladder could add more than $200 million a year to Botox sales, Fox News reports.

The drug also has been approved by the FDA for migraine prevention, upper-limb spasticity, eyelid spasms and neck pain from cervical dystonia, among other things. "Allergan has a long-standing commitment to study the potential of Botox to treat a number of different medical conditions," Allergan Chief Scientific Officer Scott Whitcup, said.